Summary

Intraoperative radiotherapy (IORT) is a method of cancer treatment in which a large single dose of radiation is delivered to the tumour or tumour bed at the time of surgical exposure. Although this approach has been under investigation since the early 1900s, it is still regarded as experimental in some respects.

The rationale for the use of IORT is to improve the accuracy and level of the dose of radiation delivered to cancerous cells without increasing the damage to surrounding normal tissues.

The primary aim of IORT is to improve locoregional tumour control. In most cases IORT has been used with curative intent, with improved local tumour control intended to translate into improved patient survival.

In its current form IORT involves the delivery of high energy electrons, via a rigid treatment cone, to the tumour area. Normal tissues are pushed outside the cone. The area of treatment may involve unresectable tumour, proven residual disease remaining after resection, or completely resected tumour sites where local recurrence after resection is likely. IORT is delivered both alone and in conjunction with preoperative or postoperative external beam fractionated radiation, and with chemotherapy.

Late stage cancer patients, with either primary or recurrent tumours, are the primary focus of IORT treatment. With better IORT treatment outcomes in patients with favourable surgical margins, there is some trend towards the use of IORT in earlier stage patients.

IORT is primarily employed for the treatment of intra-abdominal and pelvic tumours; pancreatic, rectal and gastric carcinomas in particular. IORT has lesser applications for the treatment of tumours at other abdominal sites such as the cervix, biliary tract and prostate; and non-abdominal sites including the lung, head and neck, and extremities.

The majority of data available for IORT focus on the assessment of the safety and feasibility of including IORT in conventional treatment regimens. The quality of data on the efficacy of IORT is generally poor, with few randomised controlled trials, typically small series, and limited outcome measures.

The data available suggest limited efficacy in terms of an effect on overall patient survival. For some cancers there is evidence of a significant effect on local tumour control. This is considered to improve patient quality-of-life through prevention of the pain and discomfort associated with local disease progression. There is limited quantification of quality-of-life improvement in the literature.

The complications arising from IORT use can be significant. Complications need to be considered in the context of late stage patients receiving treatment and failure to achieve locoregional tumour control.

IORT may be delivered in non-dedicated facilities where patient transport is required between surgical and radiation facilities, or in dedicated facilities where surgery and radiation can be performed in a single unit. Although the potential for wound infection and patient trauma is greater in non-dedicated facilities, the literature suggests that prob1ems with infection control are the major drawbacks of these facilities.

The dedicated facility proposed by the Royal Prince Alfred Hospital, Sydney (NSW), which would involve the attachment of a radiation suite to two surgical theatres, potentially offers efficiencies in IORT scheduling and delivery.

The number of patients available for treatment at the proposed facility would depend not only on the incidence of different tumour types, but also on the number of patients with appropriately staged, non-metastatic disease, and on referral patterns.

The facility at the Royal Prince Alfred Hospital would predominantly treat patients with pelvic tumours with curative intent. A subset of patients, with unresectable pancreatic cancer and metastatic melanoma with abdominal metastases, would be treated with palliative intent.

Details of the equipment required for the establishment and operation of the Royal Prince Alfred Hospital facility appear consistent with those described in the literature. The costs associated with the facility are difficult to assess as few economic data are available for IORT. Further economic analysis is required to determine the cost-effectiveness of this technology.

The Royal Prince Alfred Hospital possesses the requirements for the implementation of this complex and multidisciplinary technology. The design of the proposed facility, and focus on the treatment of pelvic cancers, are in accordance with the literature on IORT planning.

The main issues to decide are the extent to which a largely experimental technique should be supported within the State's health care system, the number of cases the facility would treat and the associated referral requirements.

Should the facility be established, it would be important for there to be systematic collection of clinical and economic data and follow-up of patients, with a particular focus on quality-of-life outcomes.